JLO · Enzymatic (Glutathione Reductase), Glutathione
Clinical Chemistry · 21 CFR 862.1365 · Class 1
Overview
| Product Code | JLO |
|---|---|
| Device Name | Enzymatic (Glutathione Reductase), Glutathione |
| Regulation | 21 CFR 862.1365 |
| Device Class | Class 1 |
| Review Panel | Clinical Chemistry |
Identification
A glutathione test system is a device intended to measure glutathione (the tripeptide of glycine, cysteine, and glutamic acid) in erythrocytes (red blood cells). Glutathione measurements are used in the diagnosis and treatment of certain drug-induced hemolytic (erythrocyte destroying) anemias due to an inherited enzyme deficiency.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9
Recent Cleared Devices (0 of 0)
No cleared devices on record.
